SPL v1
SPL
SPL Set ID 4744e501-f12a-6d25-e063-6394a90a2574
Route
TOPICAL
Published
Effective Date 2022-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (6.5 g) Zinc Oxide (3.5 g) Titanium Dioxide (7.75 g)
Inactive Ingredients
Lycium Chinense Fruit Sodium Chloride Ceresin Cornus Officinalis Fruit Gardenia Jasminoides Fruit Ethylhexylglycerin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Synthetic Beeswax Schisandra Chinensis Fruit Mica Cyclopentasiloxane Butylene Glycol 1,2-hexanediol Sorbitan Sesquioleate Disteardimonium Hectorite Water Ferrous Oxide Caprylic/capric Triglyceride Ethylhexyl Palmitate Alumina Cyclohexasiloxane Tin Oxide Hexyl Laurate Crataegus Laevigata Fruit Bacillus Polyfermenticus Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Tocopherol Dimethicone Polyglyceryl-4 Isostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-28

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Use helps prevent sunburn

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damage or broken skin

Warnings

For external use only

Directions

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor
Other Information

Protect this product from excessive heat and direct sun light.

Active Ingredients

Octinoxate 6.5%

Titanium Dioxide 7.75%

Zinc Oxide 3.5%

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Ethylhexyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric Triglyceride, 1,2-Hexanediol, Sorbitan Sesquioleate, Mica, Alumina, Disteardimonium Hectorite, Synthetic Beeswax, Sodium Chloride, Ceresin, Dimethicone, Polyglyceryl-4 Isostearate, Hexyl Laurate, Ethylhexylglycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Tin Oxide, Tocopherol, Schisandra Chinensis Fruit Extract, Lycium Chinense Fruit Extract, Cornus Officinalis Fruit Extract, Crataegus Oxyacantha Fruit Extract, Bacillus Ferment, Gardenia Jasminoides Fruit Extract, Iron Oxides (CI 77492, CI 77491, CI 77499)

Questions Or Comments?

Visit www.purlisse.com.

Principal Display Panel – Radiant Glow Illuminating Bb Cream Sunscreen Spf 30 Light Medium

pūrlisse

Radiant Glow

ILLUMINATING

BB

CREAM

SUNSCREEN

SPF 30

oil free

moisturizing

natural-looking coverage

illuminated finish

for normal – dry skin

even sensitive

1.4 fl. oz. / 40 mL


Structured Label Content

Uses

Use helps prevent sunburn

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damage or broken skin

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor
Other Information

Protect this product from excessive heat and direct sun light.

Active Ingredients

Octinoxate 6.5%

Titanium Dioxide 7.75%

Zinc Oxide 3.5%

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Ethylhexyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric Triglyceride, 1,2-Hexanediol, Sorbitan Sesquioleate, Mica, Alumina, Disteardimonium Hectorite, Synthetic Beeswax, Sodium Chloride, Ceresin, Dimethicone, Polyglyceryl-4 Isostearate, Hexyl Laurate, Ethylhexylglycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Tin Oxide, Tocopherol, Schisandra Chinensis Fruit Extract, Lycium Chinense Fruit Extract, Cornus Officinalis Fruit Extract, Crataegus Oxyacantha Fruit Extract, Bacillus Ferment, Gardenia Jasminoides Fruit Extract, Iron Oxides (CI 77492, CI 77491, CI 77499)

Questions Or Comments? (Questions or comments?)

Visit www.purlisse.com.

Principal Display Panel – Radiant Glow Illuminating Bb Cream Sunscreen Spf 30 Light Medium (Principal Display Panel – Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium)

pūrlisse

Radiant Glow

ILLUMINATING

BB

CREAM

SUNSCREEN

SPF 30

oil free

moisturizing

natural-looking coverage

illuminated finish

for normal – dry skin

even sensitive

1.4 fl. oz. / 40 mL


Advanced Ingredient Data


Raw Label Data

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